Correction to lacto-N-tetraose regulation: what infant nutrition manufacturers must review

Key data

Manufacturers of infant formulas and functional supplements using lacto-N-tetraose must review their technical documentation and labeling. The European Commission published on 8 September 2026 a rectification to Commission Implementing Regulation (EU) 2020/484, which previously authorized this oligosaccharide from human milk as a novel food in the European market.

The correction also affects Commission Implementing Regulation (EU) 2017/2470, which is the consolidated list of all novel foods authorized in the EU under the framework of Regulation (EU) 2015/2283. Any company marketing products with this ingredient must verify that its technical sheets, labels and conditions of use reflect the corrected terms and not those of the original text.

What does this regulation establish?

Lacto-N-tetraose is an oligosaccharide naturally present in human milk. Its use in the European market is regulated as a "novel food" under Regulation (EU) 2015/2283, which requires express authorization before marketing any ingredient of this type.

In 2020, Commission Implementing Regulation (EU) 2020/484 formally authorized its commercialization. That same regulation modified the list of authorized novel foods contained in Commission Implementing Regulation (EU) 2017/2470, which acts as the central register of all ingredients permitted under this framework.

The rectification published now corrects errors or inaccuracies detected in the original 2020 text. Although the publication does not detail the exact content of the corrections, its legal effect is clear: the corrected text prevails over the original, and companies must operate in accordance with the rectified terms.

Economic and operational impact

The direct economic impact of this rectification is limited for the overall food market, but may be significant for specialized operators already marketing products containing lacto-N-tetraose.

The operational costs arising from this correction are concentrated in three areas:

• Document review: Technical sheets, product specifications and regulatory documentation must be updated to reflect the corrected text.
• Labeling: If the conditions of use or ingredient names have changed in the rectification, it may be necessary to update labels and marketing materials.
• Communication with the supply chain: Distributors and B2B customers must be informed of any changes in product specifications.

The most exposed sector is infant nutrition, where lacto-N-tetraose is used as an ingredient in starter and follow-on formulas. In this segment, regulatory requirements are especially strict and any discrepancy between labeling and current regulations may result in problems with food control authorities.

Who does it affect?

• Infant formula manufacturers (starter, follow-on and growth) that incorporate lacto-N-tetraose as an ingredient.
• Manufacturers of functional food supplements that use this oligosaccharide in their formulation.
• Distributors and food chain operators that market products containing this ingredient in the European market.
• Regulatory and scientific affairs departments of food sector companies with presence in the EU.
• Food regulation advisors and consultants who manage the documentation of these products for their clients.

Practical example

A Spanish infant formula manufacturer that incorporates lacto-N-tetraose in its product range currently has its technical sheet and labeling based on the original text of Commission Implementing Regulation (EU) 2020/484, published in April 2020.

Following the publication of this rectification on 8 September 2026, the company's regulatory team must:

1. Download the corrected text published in the Official Journal of the EU and compare it with the original 2020 text.
2. Identify what conditions of use, names or specifications have changed from the previous text.
3. Assess whether those changes affect the current labeling of its products or the technical sheets delivered to distributors.
4. If there are discrepancies, plan the update of materials before food control authorities can detect the deviation.

This process is especially relevant in the infant nutrition segment, where regulatory inspections are frequent and the requirements for documentary compliance are stricter than in other food segments.

What should companies do now?

1. Locate and compare the texts: Download the rectified text and compare it with the original Commission Implementing Regulation (EU) 2020/484 (published in the OJEU L 103 of 3 April 2020) to identify exactly what has changed.
2. Audit current labeling: Verify that the labels of all products containing lacto-N-tetraose reflect the conditions of use and names in accordance with the corrected text.
3. Update technical documentation: Review technical sheets, ingredient specifications and internal regulatory documentation to align them with the rectification.
4. Inform the supply chain: Communicate to distributors, B2B customers and business partners any relevant changes in product specifications resulting from the correction.
5. Consult with the regulatory team or external advisor: If the company does not have internal resources specialized in novel food regulation, it is advisable to seek external advice to assess the real scope of the correction.

Official source

Consult complete regulation in official source

Disclaimer: This article is for informational purposes only and does not constitute legal advice. For specific decisions, consult a qualified professional. Source: https://eur-lex.europa.eu/./legal-content/AUTO/?uri=OJ:L_202690747